title: Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design.
abstract: BACKGROUND
  Home-based care in oncology is mainly reserved for patients at the end of life. Regulations regarding home delivery of cytotoxics differ across Europe, with a notable lack of practice guidelines in most countries. This has led to a lack of data addressing the feasibility of home-based administration of cytotoxic chemotherapy. In advanced non-squamous non-small cell lung cancer, pemetrexed is approved as maintenance therapy after first-line chemotherapy. In this setting, patients have the potential to be treated long-term with maintenance therapy, which, in the absence of unacceptable toxicity, is continued until disease progression. The favourable safety profile of pemetrexed and the ease of its administration by 10-minute intravenous infusion every 3 weeks make this drug a suitable candidate for administration in a home setting.
  
  
  METHODS
  Literature and regulations relevant to the home-based delivery of cytotoxic therapy were reviewed, and a phase II feasibility study of home administration of pemetrexed maintenance therapy was designed. At least 50 patients with advanced non-squamous non-small cell lung cancer, Eastern Cooperative Oncology Group performance status 0-1 and no progressive disease after four cycles of platinum-based first-line therapy are required to allow investigation of the feasibility of home-based administration of pemetrexed maintenance therapy (500 mg/m(2) every 3 weeks until progressive disease or unacceptable toxicity). Feasibility is being assessed as adherence to the home-based administration process (primary endpoint), patient safety, impact on patients' quality of life, patient and physician satisfaction with home care, and healthcare resource use and costs. Enrolment of patients from the UK and Sweden, where home-based care is relatively well developed, commenced in December 2011.
  
  
  CONCLUSIONS
  This feasibility study addresses an important aspect of maintenance therapy, that is, patient comfort during protracted home-based chemotherapy. The study design requires unusual methodology and specific logistics to address outcomes relevant to the home-delivery approach. This article presents a study design that offers a novel and reproducible model for home-based chemotherapy, and provides an up-to-date overview of the literature regarding this type of treatment.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01473563.
authors.affiliation: Eli Lilly, Neuilly sur Seine, France. bourayou_nawel@lilly.com.
authors.forename: Rohit
authors.initials: R
authors.lastname: Lal
authors.forename: Nawel
authors.initials: N
authors.lastname: Bourayou
authors.forename: Gunnar
authors.initials: G
authors.lastname: Hillerdal
authors.forename: Marianne
authors.initials: M
authors.lastname: Nicolson
authors.forename: Anders
authors.initials: A
authors.lastname: Vikstrom
authors.forename: Maria
authors.initials: M
authors.lastname: Lorenzo
authors.forename: Yulia
authors.initials: Y
authors.lastname: D'yachkova
authors.forename: Susana
authors.initials: S
authors.lastname: Barriga
authors.forename: Carla
authors.initials: C
authors.lastname: Visseren-Grul
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D005971:Glutamates / Q000008:administration & dosage*; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006699:Home Care Services; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D060046:Maintenance Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D017060:Patient Satisfaction; D000068437:Pemetrexed; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine